Macimorelin acetate - Generic Drug Details

What are the generic sources for macimorelin acetate and what is the scope of patent protection?

Macimorelin acetate is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Macimorelin acetate has eleven patent family members in ten countries.

One supplier is listed for this compound.

Summary for macimorelin acetate

International Patents:	11
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	77
What excipients (inactive ingredients) are in macimorelin acetate?	macimorelin acetate excipients list
DailyMed Link:	macimorelin acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for macimorelin acetate

Dosage:

FOR SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for macimorelin acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 3
AEterna Zentaris	Phase 3

See all macimorelin acetate clinical trials

Pharmacology for macimorelin acetate

Drug Class	Growth Hormone Secretagogue Receptor Agonist
Mechanism of Action	Growth Hormone Secretagogue Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for macimorelin acetate

V04CD	Tests for pituitary function
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for macimorelin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		DISCN	Yes	No

Expired US Patents for macimorelin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017

International Patents for macimorelin acetate

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115080
European Patent Office	1984744	METHODES ET KITS PERMETTANT DE DIAGNOSTIQUER UNE CARENCE EN HORMONE DE CROISSANCE (METHODS AND KITS TO DIAGNOSE GROWTH HORMONE DEFICIENCY)
Poland	1984744
Portugal	1984744
Spain	2404582
World Intellectual Property Organization (WIPO)	2007093820

Supplementary Protection Certificates for macimorelin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1289951	122019000074	Germany		PRODUCT NAME: MACIMORELIN, OPTIONAL IN FORM EINER ARZNEIMITTELZUSAMMENSETZUNG, OPTIONAL IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE MACIMORELIN ACETAT.; REGISTRATION NO/DATE: EU/1/18/1337 20190111
1289951	132019000000099	Italy		PRODUCT NAME: MACIMORELINA, OPZIONALMENTE NELLA FORMA DI UNA COMPOSIZIONE FARMACEUTICA, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESA MACIMORELINA ACETATO(MACIMORELIN AETERNA ZENTARIS - MACIMORELINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1337, 20190115
1289951	300999	Netherlands		PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
1289951	C201930046	Spain		PRODUCT NAME: MACIMORELINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1337; DATE OF AUTHORISATION: 20190111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1337; DATE OF FIRST AUTHORISATION IN EEA: 20190111
1289951	CA 2019 00037	Denmark		PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115

Market Dynamics and Financial Trajectory for Macimorelin Acetate

Introduction

Macimorelin acetate, marketed under the brand names Macrilen and Ghryvelin, is a groundbreaking oral drug approved for the diagnosis of adult growth hormone deficiency (AGHD). Recently, Aeterna Zentaris has made significant strides in expanding its use to diagnose childhood-onset growth hormone deficiency (CGHD). Here, we delve into the market dynamics and financial trajectory of macimorelin acetate.

Market Approval and Current Indications

Macimorelin acetate is the first and only U.S. FDA and European Commission-approved oral test for diagnosing AGHD. This approval has established a strong foundation in the endocrinology market, particularly for adult patients[1][4][5].

Expansion into Pediatric Market

Aeterna Zentaris has recently completed the pivotal DETECT-trial, a multicenter, open-label study evaluating the efficacy and safety of macimorelin acetate as a growth hormone stimulation test (GHST) in pediatric patients with suspected CGHD. This trial, which enrolled 100 subjects in Europe and North America, marks a significant milestone in expanding the drug's indications to include children[1][4].

Clinical Trial Outcomes and Future Data

The successful completion of the DETECT-trial is anticipated to lead to the presentation of top-line data and full study results in the third quarter of 2024. Positive outcomes from this trial could significantly expand the market for macimorelin acetate, providing a unique diagnostic tool for CGHD and enhancing patient care in pediatric endocrinology[1][4].

Market Potential

The expansion into the pediatric market holds substantial potential for growth. Growth hormone deficiency is a condition that affects both adults and children, and having a diagnostic tool that is safer, easier, and equally accurate could capture a larger share of the endocrinology market. This expansion could also attract new partnerships and licensing agreements, further bolstering the drug's market presence[1][4].

Financial Performance of Aeterna Zentaris

Aeterna Zentaris's financial performance is closely tied to the success of macimorelin acetate. As of December 31, 2023, the company had $34.0 million in cash and cash equivalents. The company reported a net loss of $16.6 million for the full year 2023, which is an improvement from the $22.7 million net loss in 2022. This reduction is largely due to the absence of non-recurring impairment charges and an increase in net other income[2].

Revenue Trends

The company's revenue has seen fluctuations, primarily due to the termination of the agreement with Novo Nordisk Healthcare in May 2023. Total revenue for the three-month period ended December 31, 2023, was $0.1 million, down from $2.5 million in the same period in 2022. However, the company is optimistic about future revenues, especially with the potential approval and commercialization of macimorelin acetate for pediatric use[2].

Operating Expenses

Operating expenses have decreased significantly, from $29.2 million in 2022 to $22.5 million in 2023. This decrease is attributed to lower research and development expenses and the absence of impairment charges. Despite this, the company still faces challenges in raising capital and securing financing for its ongoing operations[2].

Strategic Partnerships and Licensing Agreements

Aeterna Zentaris has a history of strategic partnerships, including the previous agreement with Novo Nordisk Healthcare for the marketing rights of macimorelin acetate in the U.S. and Canada. Although this agreement was terminated, the company is actively seeking new partnerships to support the late-stage development, marketing, and distribution of its products. Successful partnerships could significantly enhance the financial trajectory of macimorelin acetate[2][3].

Risks and Uncertainties

Despite the promising market dynamics, there are several risks and uncertainties associated with the development and commercialization of macimorelin acetate. These include the ability to raise capital, global instability due to the COVID-19 pandemic and geopolitical conflicts, and the need for regulatory approvals. Investors are cautioned not to place undue reliance on forward-looking statements due to these uncertainties[2].

Competitive Landscape

The diagnostic market for growth hormone deficiency is relatively niche, but the approval of macimorelin acetate for adult use and its potential approval for pediatric use positions it as a leader in this segment. The drug's unique oral administration and safety profile provide a competitive edge over traditional intravenous tests[5].

Future Outlook

The future outlook for macimorelin acetate is promising, especially with the impending release of top-line data from the DETECT-trial. Positive results could lead to regulatory approval, expanding the drug's market and potentially attracting new investors and partners. Aeterna Zentaris's diversified portfolio and focus on areas of significant unmet medical need further support the long-term financial trajectory of the company and its lead product[1][4].

Key Takeaways

• Market Expansion: Macimorelin acetate is poised to expand its market presence with potential approval for diagnosing CGHD.
• Financial Performance: Aeterna Zentaris's financials are improving, but the company faces challenges in raising capital and securing financing.
• Strategic Partnerships: New partnerships are crucial for the successful commercialization of macimorelin acetate.
• Risks and Uncertainties: Global instability, regulatory approvals, and capital raising are key risks.
• Competitive Edge: Macimorelin acetate's unique oral administration and safety profile provide a competitive advantage.

FAQs

Q: What is macimorelin acetate used for?

A: Macimorelin acetate is used for the diagnosis of adult growth hormone deficiency (AGHD) and is under investigation for the diagnosis of childhood-onset growth hormone deficiency (CGHD).

Q: What is the current status of the DETECT-trial?

A: The DETECT-trial has completed its last patient visit, and top-line data is expected to be reported in the third quarter of 2024.

Q: How does macimorelin acetate compare to traditional diagnostic tests?

A: Macimorelin acetate offers a safer, easier, and equally accurate oral test compared to traditional intravenous tests.

Q: What are the financial challenges faced by Aeterna Zentaris?

A: Aeterna Zentaris faces challenges in raising capital and securing financing to continue its operations, despite improving financial performance.

Q: What are the potential risks associated with the development of macimorelin acetate?

A: Risks include global instability, regulatory approval uncertainties, and the need for strategic partnerships to support commercialization.

Sources

1. Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency. Biospace.
2. Aeterna Zentaris Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Completion of Enrollment in Ongoing Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency. GlobeNewswire.
3. United States Securities and Exchange Commission - Annual Reports. Annual Reports.
4. Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency. Drug Development.
5. Macimorelin Test for Adult Growth Hormone Deficiency. FDA.